This invention relates to facilitating insertion of packing material into a cavity in the human body and, in particular, to treating nose hemorrhages.
Nasal cavity or sinus cavity hemorrhaging is commonly treated by packing such a cavity with an absorbent foam material. The absorbent foam material serves two primary purposes. First, it absorbs the blood to prevent possible aspiration of the blood by the patient. Second, it averts the flow of blood by applying pressure to the ruptured blood vessel due to expansion of the absorbent foam material thereby acting as a hemostat.
At present, there are a number of devices that apply hemostatic pressure to control a hemorrhage in the nose and absorb blood associated with the hemorrhage. However, several of these devices require manual insertion of the absorbent material. For example, U.S. Pat. No. 4,030,504 to Doyle issued Jun. 21, 1977 and entitled xe2x80x9cNasal Hemostat and Method of Construction of Nasal Hemostatxe2x80x9d uses an expandable absorbent material contoured to conform to the nasal cavity that must be inserted and positioned by hand.
Other known devices are typically formed or adapted at the time of use. For example, a physician will typically trim a piece of expandable absorbent material to the appropriate size, attach a suture to the absorbent material to facilitate retrieval, and manually insert the device into the patient""s nasal or sinus cavity. The absorbent material then expands upon contact with blood. This expansion results in hemostatic pressure being applied to the ruptured blood vessel resulting in the arrest of blood flow. The absorbent material is then retrieved from the cavity by means of the attached suture.
Other body fluid-absorbing devices are also known. For example, catamenial devices that are used in a different application are described in U.S. Pat. No. 3,015,332 to Brecht issued Jan. 2, 1962 and entitled xe2x80x9cApplicator,xe2x80x9d U.S. Pat. No. 3,103,929 to Brecht issued Sep. 17, 1963 and entitled xe2x80x9cCatamenial Device,xe2x80x9d U.S. Pat. No. 3,101,713 to Sargent issued Aug. 27, 1963 and entitled xe2x80x9cTampon Applicator,xe2x80x9d and U.S. Pat. No. 3,433,225 to Voss issued Mar. 18, 1969 and entitled xe2x80x9cHygenic Devices and Methods of Making The Same.xe2x80x9d These catamenial devices, however, would be inappropriate for use in a nose cavity. For example, the absorbent material used in these catamenial devices is meant to merely absorb blood flow and is not meant to apply hemostatic pressure to stop blood flow. In addition, the circular cross section of the barrel and absorbent material used in the catamenial devices would be inappropriate for use in a nose cavity since the bone and cartilage structures of the cavity define a non-circular cross-section.
Therefore, these known nose and catamenial devices might require a significant amount of manual manipulation, may be time consuming to use, can result in a significant amount of patient discomfort, or are inappropriate for use in the nose. A syringe type applicator that inserts absorbent packing material into nose cavities has been developed by the inventor of the present invention to overcome the drawbacks associated with these other prior art devices. This syringe type device is disclosed in U.S. Pat. No. 4,895,559 to Shippert, issued Jan. 23, 1990 and entitled xe2x80x9cNasal Pack Syringe.xe2x80x9d However, this syringe type applicator may at times have difficulty expelling the packing material from the syringe, particularly when the contents are moisture sensitive causing the material to swell inside a syringe. Additionally, syringe type applicators can be more costly to make and assemble because of the number of parts.
Accordingly, a need exists for non-syringe type devices (i.e., no syringe plunger) that have fewer parts, are inexpensive to manufacture and can effectively insert an absorbent material into a human body cavity, including a hemorrhaging nose cavity that has a severely deviated canal, with a minimum amount of manual manipulation. The present invention satisfies such needs and provides related advantages.
The present invention provides an efficient, relatively painless and inexpensive way of delivering absorbent packing material to a patient""s body cavity to absorb blood or other fluids and to apply hemostatic pressure to inhibit blood flow if present. The invention has a desirable containment feature in that contact with any blood that is present can be limited to the invention components and not spread to the operator or user thereof or elsewhere. The insertion device of the present invention can be characterized as having two components: (a) a single unit introducer member, and (b) a liquid absorption assembly.
The introducer member has a hollow volume and an outlet for the liquid absorption assembly to exit when expelled into the nasal or sinus cavity. In one embodiment, the hollow volume is closed in that it is defined by a single body member or shaft having two parallel wide sides and two parallel narrow sides to create a substantially rectangular cross section. The cross section defines the outlet, which is located at the distal end of the introducer member and is sized to hold the proximal end of the liquid absorption assembly securely in place until the absorbent member is expelled into the nose cavity as explained in more detail below. The walls are sufficiently strong (i.e. stiff) to hold the liquid absorption assembly in place. However, the narrow side walls can, but not necessarily, be made of thicker material than the wide side walls to provide a more solid platform for the absorbent member.
Alternatively, the introducer member has an open hollow volume defined by an elongated opening. In one embodiment, the introducer member includes a main body section and a pivotal body section formed by cut-out portions in the first and second side walls, an intermediate or connecting wall, and an elongated opening opposite the intermediate wall. In a further embodiment, the introducer member includes a single body having first and second side walls, an intermediate wall and an elongated opening opposite the intermediate wall without cut-out portions in the side walls.
The side and intermediate walls of the open volume embodiments are sufficiently strong to hold the liquid absorption assembly in place. However, the intermediate wall can, but not necessarily, be made of thicker material than the side walls to provide a more solid platform for the liquid absorption assembly as it is disengaged from the introducer member. In the embodiment having a pivotal body section, the intermediate wall beneath the cut-out portions is sufficiently flexible to allow pivotal movement of the pivotal body section relative to the main body section during the expulsion of the liquid absorption assembly into the nose cavity as explained in more detail below.
The elongated opening of the open volume embodiments has a length at least substantially corresponding to the lengths of the first and second side walls. The first and second side walls can be parallel or taper inwardly towards the elongated opening for a more secure holding of the liquid absorption assembly in the introducer member. Particularly in the embodiment in which the walls taper inwardly, different widths of absorption or packing material can be utilized in the same introducer member since such walls can be spread apart to accommodate reception of packing material of different widths. In addition, the height of the side walls of the introducer member can be lower than the height of the absorbent member to reduce the risk of cutting nose tissue and/or to make the introducer member less intrusive during the insertion process.
The introducer member is particularly useful when constructed of one piece and made of inexpensive disposable plastic material. The introducer can also be made of reusable plastic or metal materials.
The liquid absorption assembly includes an absorbent member having a proximal end, a distal end and a terminating section that is located closer to the proximal end than the distal end. A majority of the length of the absorbent member including the distal end extends exteriorly from the outlet of the introducer member when the introducer member and the absorbent member are positioned for inserting the absorbent member into a nose cavity, while the proximal end is held by the introducer member. In one embodiment, at least two-thirds of the length of the absorbent member, and preferably at least about eighty percent, extends exteriorly of the introducer member when the absorbent member is positioned for expelling into a nose cavity. The length of the absorbent member preferably extends from the nasal opening to the posterior margin of the turbinates and eustachian tube orifice.
The terminating section of the absorbent member can, but not necessarily, be of a first size that is larger than at least the size of the proximal end and can also be larger than the size of the distal end. The proximal end of the absorbent member is disposed in the hollow volume of the introducer member and exits from the outlet of the introducer member when the absorbent member is expelled into the nose cavity. The terminating section can also include a cuff having a marker for use in identifying the location of the absorbent member in the nose cavity, as well as in other parts of the human body when the absorbent member is inadvertently aspirated or swallowed. In the embodiment of the introducer member having a pivotal body and main body sections, the terminating section is located adjacent to the cutout portions of the introducer member. In the embodiment without cut-out portions, the terminating section lies outside and adjacent to the outlet of the introducer member.
The absorbent member can be made of any material capable of expanding as it absorbs blood or other fluids. Preferably, the absorbent member can be compressed in at least two directions prior to use.
The liquid absorption assembly includes a string member, which when pulled expels the absorbent member from the introducer member into the nose cavity. The string member can be attached to the proximal end or terminating section of the absorbent member. Alternatively, the string member can be attached to a portion or throughout the length of the absorbent member (for example, sewn down the length of the absorbent member) and can extend from the absorbent member either from the proximal or distal end. Once the absorbent member is properly positioned in a nose cavity, the string member can be secured externally of the cavity, for example, taped to the patient""s face to assist in the prevention of aspiration or swallowing of the absorbent member. Preferably, the string member forms a loop that can be secured by wrapping the loop around an ear of the patient. After the absorbent material has served its purpose, it can be removed from the nose cavity by pulling the string member out the nasal opening.
The present invention further provides methods for inserting an absorbent member into a nose cavity. The methods are generally accomplished by:
(a) providing an introducer member holding an absorbent member, wherein the absorbent member is attached to a string member;
(b) positioning the absorbent member in a cavity located in a nose; and
(c) expelling the absorbent member from the introducer member into the cavity using the string member.
In one embodiment, the introducer member has a pivotal body section which is pivoted during the expulsion of the absorbent member from the introducer member by the string member. In this embodiment, pulling on the string member will bend the intermediate wall beneath the cut-out portions of the introducer member causing the main body section of the introducer to pivot downward relative to the pivotal body section, which facilitates the removal of the pivotal body section out the nasal opening while expelling the absorbent member into the desired nose cavity. In an alternative embodiment, the introducer member has a single body with the side walls that are parallel or tapered toward an elongated opening. In both embodiments, the absorbent member preferably extends above the elongated opening to reduce the risk of tissue damage.
In yet another embodiment, the introducer member has a single body member or single shaft such that pulling on the string member facilitates the removal of the shaft tip out the nasal opening while expelling the absorbent member into the nose cavity.
The methods of the present invention further comprise the step of connecting a portion of the string member on or adjacent to a patient""s face to avoid, after the absorbent member is positioned in the nose cavity, aspiration of the absorbent member. For example, the string member can be taped to a patient""s face. Alternatively, the string member can be in the form of a loop wrapped around the patient""s ear. Once the absorbent member has served its purpose, it can be withdrawn from the nose cavity by pulling on the attached string member.
Based on the foregoing summary, a number of salient features of the present invention are recognized. A foam pack device is provided having a reduced number of parts for absorbing blood and applying pressure in a human body cavity after expansion of the foam packet. Although the application of the present invention with a nose cavity is described, other cavities in the human body are applicable including ear cavities, appropriate tissue-formed cavities and the vagina. The device also functions to contain blood so that unwanted contact and spreading thereof are avoided.
Additional advantages of the present invention will become readily apparent from the following description when taken in conjunction with the accompanying drawings.